{"active_ingredient":["Active ingredient (in each film-coated tablet) Fexofenadine HCL 180 mg"],"ask_doctor":["Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose."],"do_not_use":["Do not use if you have ever had an allergic reaction to this product or any of its ingredients."],"dosage_and_administration":["Directions adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor"],"dosage_and_administration_table":["<table><col/><col/><tbody><tr><td styleCode=\" Botrule Toprule Lrule Rrule\" valign=\"top\"> adults and children 12 years of age and over</td><td styleCode=\" Botrule Rrule\" valign=\"top\"> take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours</td></tr><tr><td styleCode=\" Botrule Lrule Rrule\" valign=\"top\"> children under 12 years of age</td><td styleCode=\" Botrule Rrule\" valign=\"top\"> do not use</td></tr><tr><td styleCode=\" Botrule Lrule Rrule\" valign=\"top\"> adults 65 years of age and older</td><td styleCode=\" Botrule Rrule\" valign=\"top\"> ask a doctor</td></tr><tr><td styleCode=\" Botrule Lrule Rrule\" valign=\"top\"> consumers with kidney disease</td><td styleCode=\" Botrule Rrule\" valign=\"top\"> ask a doctor</td></tr></tbody></table>"],"effective_time":"20260101","id":"48d2c7f6-8550-1b9c-e063-6394a90ada4e","inactive_ingredient":["Inactive ingredients anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"openfda":{"application_number":["ANDA204507"],"brand_name":["Fexofenadine Hydrochloride"],"generic_name":["FEXOFENADINE HCL"],"manufacturer_name":["Northwind Health Company, LLC"],"original_packager_product_ndc":["0904-7050"],"package_ndc":["51655-231-52","51655-231-26"],"product_ndc":["51655-231"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["997420"],"spl_id":["48d2c7f6-8550-1b9c-e063-6394a90ada4e"],"spl_set_id":["f2b6c157-1af1-8d43-e053-2995a90aaf1a"],"substance_name":["FEXOFENADINE HYDROCHLORIDE"],"unii":["2S068B75ZU"]},"package_label_principal_display_panel":["Principal Display Panel COMPARE TO the active ingredient in ALLEGRA® ALLERGY 24 HOUR* FEXOFENADINE HYDROCHLORIDE USP 180 mg Antihistamine ALLERGY RELIEF 24-HOUR Relief of: sneezing Runny nose Itchy, watery eyes Itchy nose or throat Indoor and Outdoor Allergy Relief Non-Drowsy Capsule Shaped Tablets *This product is not manufactured or distributed by Chattem Inc., distributor of Allegra® Allergy 24 hour TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: MAJOR® PHARMACEUTICALS 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152","Principal Display Panel NDC: 51655-231-52 Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call: 1-800-616-2471"],"set_id":"f2b6c157-1af1-8d43-e053-2995a90aaf1a","spl_product_data_elements":["Fexofenadine Hydrochloride Fexofenadine HCl SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERRIC OXIDE RED FERRIC OXIDE YELLOW ANHYDROUS LACTOSE STARCH, CORN POLYETHYLENE GLYCOL, UNSPECIFIED LACTOSE MONOHYDRATE STEARIC ACID TITANIUM DIOXIDE FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SG;202"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["Other information each tablet contain : sodium 8 mg store between 20 to 25°C (68 to 77°F) protect from excessive moisture this product meets the requirements of USP Dissolution Test 2"],"version":"2","warnings":["Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"when_using":["When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)"]}